Procalcitonin to Guide Obtaining Bloodcultures in the ICU Intensive Care Infection Score (ProBIC/ICIS)

Procalcitonin to Guide Obtaining Bloodcultures in the ICU. Intensive Care Infection Score.

PROBIC

Rationale: Procalcitonin measurements can reduce the number of blood cultures in the ICU.

Objective: The investigators suggest that PCT is a marker for blood stream infection in all patients in the ICU in whom attending physicians/ intensivists order blood culturing in the suspicion of microbial infection. The investigators want to demonstrate that its use for guiding blood culturing is cost-effective and safe compared with blood cultures alone.

Study design: Prospective, non- inferiority, multicenter, single-blinded, cluster- randomised cross-over clinical trial.

Intervention (if applicable): The intensive care units will be allocated into two groups: a control group (blood culture) and the intervention group (procalcitonin).

Main study parameters/endpoints: Safety, expressed as mortality at day 28 and 90, with a mortality difference not exceeding a between groups difference of 10% by non-inferiority analysis.

Cost-effectiveness, expressed in euro, calculated by deducting costs of procalcitonin testing from saved blood cultures compared with standard treatment spending on blood cultures in the control group.

ICIS

Rationale: The aim was to evaluate the Intensive Care Infection Score (ICIS) in predicting microbial infection and its sequelae in critically ill patients in whom attending physicians/ intensivists order blood culturing in the suspicion of microbial infection.

Objective: Because of the complexity of the pathophysiology of systemic inflammation it is unlikely that a single parameter will have sufficient diagnostic accuracy for infection. Therefore we will study combining parameters producing a diagnostic score.

Study design: Prospective, multicenter, cohort trial. Supplement for the control arm of the ProBIC study.

Intervention (if applicable): Blood is drawn for daily routine laboratory measurements and collected in K3EDTA aliqnots. The ICIS score is composed of five blood-cell derived parameters which can be extracted using the same aliqnots.

Main study parameters/endpoints: To develop and evaluate a blood- cell derived score to enable the diagnosis of microbial infection, its likelihood, its invasiveness and severity.

Study Overview

• Status: Completed
• Conditions: Infection
• Intervention / Treatment: Other: Procalcitonin

• Study Type: Interventional
• Enrollment (Actual): 1130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015CE
      • Erasmus MC
    • Rotterdam, Zuid Holland, Netherlands, 3079DZ
      • Maasstad ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients will need to be over the age of 18 and suffering from an assumed infection deemed clinically worthy for blood culturing.

Exclusion Criteria:

• Uncontrolled malignancy
• Immunosuppressive or immunostimulatory therapy
• Neutropenia, defined as leukocyte count less then 0.5x109/L
• Moribund patients
• Predetermined illness with an expected death within 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention group, procalcitonin; procalcitonin to guid obtaining bloodcultures in the ICU	Other: Procalcitonin; Procalcitonin to guide obtaining bloodcultures
No Intervention: Control group, ICIS, procalcitonin; Measurement of PCT and ICIS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1. Safety, expressed as mortality at day 28 and 90, with a mortality difference not exceeding a between groups difference of 10% by non-inferiority analysis.	90 days

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Patrick van der Geest, MD, Erasmus MC

Publications and helpful links

General Publications

• van der Geest PJ, Mohseni M, Nieboer D, Duran S, Groeneveld ABJ. Procalcitonin to guide taking blood cultures in the intensive care unit; a cluster-randomized controlled trial. Clin Microbiol Infect. 2017 Feb;23(2):86-91. doi: 10.1016/j.cmi.2016.10.004. Epub 2016 Oct 13.
• van der Geest PJ, Mohseni M, Linssen J, Duran S, de Jonge R, Groeneveld AB. The intensive care infection score - a novel marker for the prediction of infection and its severity. Crit Care. 2016 Jul 7;20(1):180. doi: 10.1186/s13054-016-1366-6.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 6, 2013

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 13, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: NL 38603.078.11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No